Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)

February 25, 2021 updated by: Bayer

A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Dose Finding Phase II Trial Exploring the Pharmacodynamic Effects, Safety and Tolerability, and Pharmacokinetics of Four Dose Regimens of the Oral sGC Stimulator BAY1021189 Over 12 Weeks in Patients With Worsening Heart Failure and Preserved Ejection Fraction (HFpEF)

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
477

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
    • Queensland
      • Brisbane, Queensland, Australia, 4029
      • Brisbane, Queensland, Australia, 4064
      • Redcliffe, Queensland, Australia, 4020
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
  • Austria
      • Salzburg, Austria, 5020
      • Wien, Austria, 1220
      • Wien, Austria, 1090
    • Niederösterreich
      • St. Pölten, Niederösterreich, Austria, 3100
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4010
      • Linz, Oberösterreich, Austria, 4020
    • Steiermark
      • Graz, Steiermark, Austria, 8036
  • Belgium
      • Brugge, Belgium, 8000
      • Bruxelles - Brussel, Belgium, 1200
      • Gent, Belgium, 9000
      • Gilly, Belgium, 6060
      • HUY, Belgium, 4500
      • MOL, Belgium, 2400
      • Mechelen, Belgium, 2800
      • Roeselare, Belgium, 8800
  • Bulgaria
      • Burgas, Bulgaria, 8018
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1527
      • Sofia, Bulgaria, 1202
      • Sofia, Bulgaria, 1309
      • Stara Zagora, Bulgaria, 6000
  • Canada
      • Quebec, Canada, G1V 4G5
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
      • Montreal, Quebec, Canada, H2W 1T8
      • Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1C3
      • Sherbrooke, Quebec, Canada, J1G 2E8
  • Czechia
      • Kromeriz, Czechia, 767 01
      • Praha 10, Czechia, 10034
      • Praha 2, Czechia, 12808
      • Praha 4, Czechia, 140 21
      • Praha 6, Czechia, 169 02
  • Denmark
      • Aalborg, Denmark, 9000
      • Holbaek, Denmark, 4300
      • Randers, Denmark, 8930
  • France
      • BRON Cedex, France, 69677
      • Pessac, France, 33604
      • Rouen, France, 76031
      • Toulouse, France, 31403
  • Germany
      • Hamburg, Germany, 20246
    • Baden-Württemberg
      • Bad Krozingen, Baden-Württemberg, Germany, 79189
    • Bayern
      • München, Bayern, Germany, 80331
    • Hessen
      • Bad Homburg, Hessen, Germany, 61348
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
      • Münster, Nordrhein-Westfalen, Germany, 48149
    • Saarland
      • Homburg, Saarland, Germany, 66421
    • Thüringen
      • Erfurt, Thüringen, Germany, 99089
  • Greece
      • Athens, Greece, 11527
      • Chaidari, Greece, 12462
      • Nea Ionia / Athens, Greece, 142 33
  • Hungary
      • Budapest, Hungary, 1097
      • Kistarcsa, Hungary, H-2143
      • Szekesfehervar, Hungary, 8000
  • Israel
      • Afula, Israel, 1834111
      • Ashkelon, Israel, 7830604
      • Hadera, Israel, 3810101
      • Haifa, Israel, 3109601
      • Jerusalem, Israel, 9103102
      • Petah Tikva, Israel, 4941492
      • Rehovot, Israel, 7610001
      • Tel Aviv, Israel, 6423906
      • Tiberias, Israel, 1528001
      • Zrifin, Israel, 7030000
  • Italy
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
      • Brescia, Lombardia, Italy, 25123
      • Milano, Lombardia, Italy, 20017
      • Milano, Lombardia, Italy, 20149
      • Pavia, Lombardia, Italy, 27100
    • Marche
      • Ancona, Marche, Italy, 60126
    • Toscana
      • Arezzo, Toscana, Italy, 52040
  • Japan
      • Fukui, Japan, 910-8526
      • Hiroshima, Japan, 734-8530
      • Kumamoto, Japan, 862-8505
      • Nagasaki, Japan, 850-8555
      • Osaka, Japan, 558-8558
      • Tokushima, Japan, 770-8539
      • Toyama, Japan, 930-8550
    • Fukuoka
      • Iizuka, Fukuoka, Japan, 820-8505
    • Hyogo
      • Himeji, Hyogo, Japan, 670-0981
    • Ibaraki
      • Higashiibaraki, Ibaraki, Japan, 311-3193
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8650
    • Kagawa
      • Takamatsu, Kagawa, Japan, 760-0018
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-5188
      • Yokohama, Kanagawa, Japan, 236-0051
      • Yokosuka, Kanagawa, Japan, 238-8567
    • Kyoto
      • Uji, Kyoto, Japan, 611-0041
    • Okinawa
      • Naha, Okinawa, Japan, 902-8511
    • Osaka
      • Sakai, Osaka, Japan, 599-8247
      • Takatsuki, Osaka, Japan, 569-1096
    • Tokushima
      • Komatsushima, Tokushima, Japan, 773-8502
    • Tokyo
      • Meguro-ku, Tokyo, Japan, 152-8902
      • Minato-ku, Tokyo, Japan, 106-0031
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
      • Heerenveen, Netherlands, 8441 PW
      • Leeuwarden, Netherlands, 8934 AD
      • Sneek, Netherlands, 8601 ZR
  • Poland
      • Bialystok, Poland, 15-276
      • Krakow, Poland, 31-202
      • Krakow, Poland, 31-121
      • Lodz, Poland, 92-213
      • Lodz, Poland, 93-513
      • Olsztyn, Poland, 10-010
      • Poznan, Poland, 61-848
      • Szczecin, Poland, 70-965
  • Portugal
      • Almada, Portugal, 2801-951
      • Lisboa, Portugal, 1649-035
      • Lisboa, Portugal, 1449-005
      • Lisboa, Portugal, 1500-650
  • Singapore
      • Singapore, Singapore, 119228
      • Singapore, Singapore, 308433
      • Singapore, Singapore, 169609
      • Singapore, Singapore, 768828
  • Spain
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08023
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
    • Cantabria
      • Santander, Cantabria, Spain, 39008
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
    • Murcia
      • El Palmar, Murcia, Spain, 30120
  • Sweden
      • Helsingborg, Sweden, 251 87
      • Karlstad, Sweden, 652 30
      • Linköping, Sweden, 581 85
      • Stockholm, Sweden, 118 83
      • Örebro, Sweden, 701 85
  • Switzerland
      • Genève, Switzerland, 1205
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
  • Taiwan
      • Kaohsiung, Taiwan, 813
      • New Taipei City, Taiwan, 220
      • Taipei, Taiwan, 11217
      • Taipei, Taiwan, 10016
      • Taoyuan, Taiwan, 333423
  • United Kingdom
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S44 5DX
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
  • United States
    • California
      • Fountain Valley, California, United States, 92708
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
      • Naples, Florida, United States, 34102
    • Georgia
      • Macon, Georgia, United States, 31201
    • Illinois
      • Chicago, Illinois, United States, 60611-2908
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-1396
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55422
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
    • New Jersey
      • Newark, New Jersey, United States, 07103
    • New York
      • Buffalo, New York, United States, 14215
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Nashville, Tennessee, United States, 37232-8802
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
  • Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization

Exclusion Criteria:

  • Intravenous inotropes at any time after hospitalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vericiguat (BAY1021189) (5 mg)
2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Drug: Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets
Experimental: Vericiguat (BAY1021189) (2.5 mg)
2.5 mg orally once daily for 12 weeks (with sham titrations)
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Experimental: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg orally once daily for 12 weeks (with sham titrations)
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Placebo Comparator: Placebo
Orally once daily for 12 weeks (with sham titrations)
Drug: Placebo
Experimental: Vericiguat (BAY1021189)(10 mg)
2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Drug: Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Time Frame: Baseline, Week 12 (end of treatment [EOT])
NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).
Baseline, Week 12 (end of treatment [EOT])
Change From Baseline to Week 12 in Left Atrial Volume (LAV)
Time Frame: Baseline, Week 12 (EOT)
Left atrial volume was measured by echocardiography.
Baseline, Week 12 (EOT)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 12 (EOT)
Blood pressure was measured after at least 10 minutes resting in a sitting position (3 measurements taken approximately 2 minutes apart).The changes in blood pressure were recorded and the mean of the three measurements was analyzed.
Baseline, Week 12 (EOT)
Change From Baseline to Week 12 in Heart Rate
Time Frame: Baseline, Week 12 (EOT)
Heart rate was measured after 10 minutes resting in a sitting position (3 measurements taken approximatly 2 minutes apart). The changes in heart rate were recorded and the mean of the three measurements was analyzed.
Baseline, Week 12 (EOT)
Number of Subjects With Clinical Events (Heart Failure Hospitalization and Cardio-vascular [CV] Mortality)
Time Frame: Baseline up to Week 16 including 12 week treatment period and 4 week follow-up period
Clinical events (heart failure and mortality) were analyzed as CV death, and HF hospitalization at specified time points.
Baseline up to Week 16 including 12 week treatment period and 4 week follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15829
  • 2013-002288-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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